QMSrs Work Instruction
Risk Management Work Instructions
This Document is the Work Instruction (WI)
for Risk Management
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 2 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
2
Introduction ......................................................................... 3
Purpose
...................................................................................
3
Scope
.......................................................................................
3
Referenced Documents
...........................................................
3
Risk Management Process .................................................... 4
Risk Management Work Instructions ..................................... 4
Risk Mangement Settings
........................................................
4
Risk Category
..........................................................................
4
Risk Criteria
.............................................................................
6
Risk Formulas
..........................................................................
8
Create New Risk
......................................................................
9
Manage Risk Score Criteria
...................................................
16
Manage Risk
.........................................................................
17
Create Mitigation Action
.......................................................
18
Manage Mitigation Action
....................................................
19
Reports
..................................................................................
20
Quality Records and Archives ............................................... 21
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 3 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
3
INTRODUCTION
This document is the Work Instruction (WI) for Risk Management
PURPOSE
This WI defines the steps that are followed to add, update and monitor the Risks
inside the organisation.
SCOPE
The WI applies to the QMSrs Tool set that accompanies this WI
REFERENCED DOCUMENTS
Doc. No.
Doc. Description
QMSrs-T-00-E
QMSRS Document Template
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 4 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
4
RISK MANAGEMENT PROCESS
This section displays the flow of the process.
RISK MANAGEMENT WORK INSTRUCTION
RISK MANGEMENT SETTINGS
RISK CATEGORY
In this section the user can add, edit and delete the risk category.
ADD RISK CATEGORY:
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Category’.
Click on ( ) sign to add new category.
Enter category name in the blank box then enter its description.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
EDIT RISK CATEGORY:
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Category’.
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 5 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
5
Click on search sign" " then select the category from the drop down list
Click on edit icon“ “beside the category that you want to edit.
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
DELETE RISK CATEGORY:
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Category’.
Click on search sign" " then select the category from the drop down list
Click on delete icon “ “beside the category that you want to delete.
To delete the Risk category click on “OK “or “Cancel “to cancel deleting.
SUB CATEGORY
ADD SUB CATEGORY
Select the main category from the drop down list.
Click on add icon " " at the top of the window.
Click on the title of the added subcategory that appears on the left side of the
window.
Change the title of sub category and enter its description.
Click on save icon “ ” to save changes that appears at the top of the
window.
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 6 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
6
EDIT SUB CATEGORY
Select the main category from the drop down list.
Click on the title of the subcategory that appears on the left side of the
window and you want to edit.
Change the title of sub category and enter its description.
Click on save icon “ ” to save changes that appears at the top of the
window.
DELETE SUB CATEGORY
Select the main category from the drop down list.
Click on the sub category that you want to delete.
Click on delete icon " " at the top of the window.
Click on “OK “or “Cancel “to cancel deleting.
RISK CRITERIA
In this section the user can add, edit and delete the criteria of the risk.
ADD RISK CRITERIA:
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Criteria’.
Click on create icon“ “.
Select the risk type from the drop down list.
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 7 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
7
Enter the new risk criteria title in the blank box then enter its description.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
EDIT RISK CRITERIA:
Go to Risk Management section in the QMS.
From Risk Management Settings ‘Risk Criteria’.
Click on edit icon“ “beside the criteria that you want to edit.
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
DELETE RISK CRITERIA:
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Criteria’.
Click on delete icon “ “beside the criteria that you want to delete.
To delete the criteria click on “OK “or “Cancel “to cancel deleting.
SEARCH RISK CRITERIA:
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Criteria’.
Click on filter icon “ “at the top of the window, then select the search
criteria. (risk type)
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 8 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
8
Fill the text field or select from the drop down list which depends on the
search criteria you choose.
RISK FORMULAS
In this section the user can add, edit and delete the risk formula
ADD RISK FORMULA
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Formulas’.
Click on create icon“ “.
Select the risk type from the drop down list.
Select the attribute from the drop down list.
Select the operator from the drop down list.
Select another attribute from the drop down list or enter a number manually.
The formula syntax will appear on the left side of the window.
Click on “Save “to save the amended data or “Cancel” to cancel the changes
EDIT RISK FORMULA
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Formulas’.
Click on edit icon“ “beside the formula that you want to edit.
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 9 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
9
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
DELETE RISK FORMULA
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Formulas’.
Click on delete icon “ “beside the formula that you want to delete.
To delete the formula click on “OK “or “Cancel “to cancel deleting.
SEARCH RISK FORMULA
Go to Risk Management section in the QMS.
From Risk Management Settings select ‘Risk Formulas’.
Click on filter icon “ “at the top of the window, then select the search
criteria (risk type)
Fill the text field or select from the drop down list which depends on the
search criteria you choose.
CREATE NEW RISK
This section explains how to add new risk
Go to Risk Management section in the QMS.
Select ‘Create New Risk .
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 10 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
10
Select the type of the risk from the drop down list.
Enter the risk ID in the blank box.
Fill the mandatory fields with the red asterisk ‘*’ and any other fields you
have data for.
Click on save icon ” to save changes that appears at the top of the
window.
Field Name
Description
Risk Details
Risk Name
Enter the name of the risk
Risk Mode
Select the mode from the drop down list (Issue,
Assumption)
Risk Category
Select the category from drop down list or add new
category by clicking on ( ) sign
Description
Enter the description (nature) of risk
Date Registered
Select the date form calendar
Risk Owner
Click on search sign" " then select from the drop
down list
Cost Centre
Select the cost centre from drop down list or add new
centre by clicking on ( ) sign
Other Cost Centre
Select the other cost centre from drop down list
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 11 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
11
RISK ESTIMATION FOR ORI RISK TYPE
Risk Estimation for Organizational, Projects
Check on organizational if the ORI Risk type is organizational
Check on project If ORI risk type is project then click on search sign " "
and select project from the drop down list.
Risk Estimation Entry Fields
Below are the fields to be completed when creating a risk with ORI type
Risk Estimation (This tab will change according to risk type)
The permanent fields are :
Probability
Select from the drop down list (List will change
according to the risk type)
Probability Value will appear automatically and its
predefined by the user
Probability Value
This is calculated value and it will change according to
the risk type
Each type of risk has its own formula and can be
predefined by the user
Risk Score
This is calculated value and it will change according to
the risk type
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 12 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
12
EDIT PROBABILITY VALUE
Click on edit icon“ “beside the probability that you want to edit.
Double click on the value of the probability that you want to change.
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
Field Name
Description
Risk Estimation
Time Impact
Select from the drop down list: Very High, High,
Medium, Low, Very Low, and Nil
Probability Value will appear automatically (predefined
by the user)
Cost Impact
Select from the drop down list: Very High, High,
Medium, Low, Very Low, and Nil
Probability Value will appear automatically (predefined
by the user)
QOS Impact
Quality of service
Select from the drop down list: Very High, High,
Medium, Low, Very Low, and Nil
Probability Value will appear automatically (predefined
by the user)
Standard Cost of
Impact
Enter standard impact cost
Exposure Value will appear automatically (predefined
by the user)
Adjusted Cost of
Impact
Enter Adjusted Impact Cost
Exposure Value will appear automatically (predefined
by the user)
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 13 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
13
MAINTAIN PROBABILITY PERCENTAGE MATRIX
The matrix represents the cost, time, and QoS impact probability percentage, which
can be determined by the criteria of the probability in the first column and the
criteria of one of the impacts in the first row.
Click on help icon“ to edit the probability percentage.
Double click on the value of the probability that you want to change.
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
RISK ESTIMATION FOR OHSAS & HACCP RISK TYPES
Risk Estimation Entry Fields
Below are the fields to be completed when creating a risk with OHSAS, HACCP types
Field Name
Description
Risk Estimation
Severity Criteria
Select from the drop down list: High, No measurable
impact, Short term reversible damage to the
environment within the facility…
or add new criteria by clicking on ( ) sign
Probability Value will appear automatically (predefined
by the user)
Criteria Limit
Select the operator from the drop down list then enter
the value of the limit
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 14 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
14
RISK ESTIMATION FOR EMS RISK TYPES
The significant rating value can be estimated using the following equation:
Rating= Risk Score + Legal/Regulatory Requirements + Nuisance + Interested Parties
+ Lack of Information + Policy Issues
Severity Score
Will appear automatically
Field Name
Description
Risk Estimation
Severity of Impact
on Env.
Select from the drop down list: High, No measurable
impact, Short term reversible damage to the
environment within the facility
or add new criteria by clicking on ( ) sign
Probability Value will appear automatically(predefined
by the user)
Severity of Impact
on Human
Select from the drop down list: High, No measurable
impact, Short term reversible damage to the
environment within the facility
or add new criteria by clicking on ( ) sign
Probability Value will appear automatically (predefined
by the user)
Complexity of
Operational Controls
Click on search sign" " then select from the drop
down list
Value will appear automatically (predefined by the user)
Legal/Regulatory
Requirements
Click on search sign" " then select from the drop
down list
Value will appear automatically (predefined by the user)
Nuisance
Click on search sign" " then select from the drop
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 15 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
15
MAINTAIN SIGINFICANT RATING
The matrix represents the rate criteria details
Click on help icon“ to edit the rate criteria.
Double click on the value of (operator, rate, and description).
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
User can add a new rate criteria details by clicking on add icon" "
down list
Value will appear automatically (predefined by the user)
Interested Parties
Click on search sign" " then select from the drop
down list
Value will appear automatically (predefined by the user)
Lack of Information
Click on search sign" " then select from the drop
down list
Value will appear automatically (predefined by the user)
Policy Issues
Click on search sign" " then select from the drop
down list
Value will appear automatically (predefined by the user)
Significant Rating
Value will appear automatically Calculated as below
Risk Score + Legal/Regulatory Requirements + Nuisance
+ Interested Parties + Lack of Information + Policy Issues
Criteria limit
Select the operator from the drop down list then enter
the value of the limit
Severity Score
Will appear automatically
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 16 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
16
MANAGE RISK SCORE CRITERIA
In this section the user can add, edit and delete the score criteria of the risk.
ADD RISK SCORE CRITERIA:
Go to Risk Management section in the QMS.
Select ‘Manage Risk Score Criteria’.
Click on create icon“ “.
Select the risk type from the drop down list.
To add Score criteria select the operator from drop down list and enter the
value
Enter the rating value in the blank box then enter its description.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
EDIT RISK SCORE CRITERIA:
Go to Risk Management section in the QMS.
Select ‘Manage Risk Score Criteria’.
Click on edit icon“ “beside the score criteria that you want to edit.
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
DELETE RISK SCORE CRITERIA:
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 17 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
17
Go to Risk Management section in the QMS.
Select ‘Manage Risk Score Criteria’.
Click on delete icon “ “beside the score criteria that you want to delete.
To delete the score criteria click on “OK “or “Cancel “to cancel deleting.
SEARCH RISK SCORE CRITERIA:
Go to Risk Management section in the QMS.
Select ‘Manage Risk Score Criteria’.
Click on filter icon “ “at the top of the window, then select the search
criteria. (risk type)
Fill the text field or select from the drop down list which depends on the
search criteria you choose.
MANAGE RISK
In this section the user can edit risk, delete a risk and use the filter to search for a
risk using varying criteria.
EDIT A RISK
Go to Risk Management section in the QMS.
Select ‘Manage Risk’.
Click on edit icon“ beside the risk that you want to edit.
Make the necessary changes.
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 18 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
18
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
DELETE A RISK
Go to Risk Management section in the QMS.
Select ‘Manage Risk’.
Click on delete icon “ “beside the risk that you want to edit.
To delete the risk click on “OK “or “Cancel “to cancel deleting.
SEARCH A RISK
Go to Risk Management section in the QMS.
Select ‘Manage Risk’.
Click on filter icon “ “at the top of the window, then select the search
criteria.
Fill the text field or select from the drop down list which depends on the
search criteria you choose.
CREATE MITIGATION ACTION
In this section the user can add risk mitigation action.
CREATE MITIGATION ACTION
Go to Risk Management section in the QMS.
Select ‘Create Mitigation Action’.
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 19 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
19
Click on search sign" " then select the risk from the drop down list.
Fill the mandatory fields with the red asterisk ‘*’ and any other fields you
have data for.
Click on save icon “ ” to save changes that appears at the top of the
window.
MANAGE MITIGATION ACTION
In this section the user can edit, delete a mitigation action and use the filter to
search for a mitigation action using varying criteria.
EDIT A MITIGATION ACTION
Field Name
Description
Mitigation Action Details
Mitigation Type
Select the type from the drop down list or add new
category by clicking on ( ) sign
Potential Impact
Enter the impact of the identified risk
Countermeasures
Enter the list of the existing and/or proposed
countermeasures against the identified risk
Action
Enter the description (nature) of action
Actionee
Click on search sign" " then select from the drop
down list
Target Close Date
Select the date form calendar
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 20 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
20
Go to Risk Management section in the QMS.
Select ‘Manage Mitigation Action ’.
Click on edit icon“ “beside the action that you want to edit.
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
DELETE A MITIGATION ACTION
Go to Risk Management section in the QMS.
Select ‘Manage Mitigation Action’.
Click on delete icon “ “beside the action that you want to delete.
To delete the risk click on “OK “or “Cancel “to cancel deleting.
SEARCH A MITIGATION ACTION
Go to Risk Management section in the QMS.
Select ‘Manage Mitigation Action’.
Click on filter icon “ “at the top of the window, then select the search
criteria.
Fill the text field or select from the drop down list which depends on the
search criteria you choose.
REPORTS
ID
QMSrs-015-E-RM-WI
Title:
QMSrs Risk Management Work Instructions
DCR ID
DCR-004
Issue No.
4
1/1/2015
PAGE 21 of 21
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
21
VIEW RISK LIST
This section displays all Risks; different filter criteria can be used (category, status,
type, Actionee, cost centre and record mode).
User can export the report.
Click on export icon" "to export the data into different format (Xls.
PDF...)
Click on "open" to open the report in the format you chose.
You can use varying criteria as follows:
Click on filter icon “ “at the top of the window, then choose the search
criteria you want.
Select from the drop down list and click on next icon" ".
To clear the result of filtration click on delete filter icon" ".
In this dynamic report, the user can choose the fields that he wants to appear in the
table by selecting from the drop down list of “display fields” that found at the top of
the page and then click on “ “icon.
QUALITY RECORDS AND ARCHIVES
Reference
Record Description
Location
Retention
QMSrs Tool
Quality Records
http://www.qmsrs.org
5 Years